New Areas of Discovery and Collaboration

Since its inception, TriCore’s Research Institute has experienced steady and continuous growth, emphasizing research in the field of infectious diseases. During the pandemic, the focus was on COVID Emergency Use Authorizations, which were crucial. The Institute is now diversifying to encompass more intricate studies, such as more complex COVID 510(k) submissions and other respiratory viruses. In addition, TRI is further broadening its scope by venturing into other clinical laboratory areas and collaborating with in vitro diagnostic companies by collecting data for novel biomarker 510(k) submissions.

Identifying gaps in diagnostic strategies is helpful to develop new ways to increase test specificity, reduce unnecessary tests, and decrease the cost of misdiagnosis.

Connective Tissue Diseases

Connective tissue diseases encompass conditions like rheumatoid arthritis (RA), lupus, polymyositis, dermatomyositis, and scleroderma. Diagnosing these diseases is often challenging. Increasing diagnostic accuracy and promptness of patient treatment are key to effective treatment of these diseases.

For example, some of the tests to detect RA include:

• Antinuclear antibody by IFA
• Rheumatoid factor (RF)
• Cyclic citrullinated peptide (CCP)
• Erythrocyte rate (ESR)
• C-reactive protein (CRP)

While these routine tests are available in labs, they lack specificity in determining the appropriate treatment for RA patients. The industry’s overall cost of misdiagnosis exceeds over $150 million per year. The ultimate goal is to identify new biomarkers that can minimize false positives and negatives, thereby optimizing RA diagnosis. TRI is collecting remnant samples of the different types of connective tissue disorders to test them using a different strategy and novel biomarkers.

Gastrointestinal (GI) Disorders

Medical scientists acknowledge that certain symptoms of colon cancer may manifest as GI bleeding or inflammatory bowel disease (IBD). When diagnosing colon cancer, healthcare providers thoroughly assess factors related to GI bleeding and inflammation. Some of the imaging techniques used to diagnose colon cancer include:

• Colonoscopy
• Flexible sigmoidoscopy
• CT colonography

Additionally, biochemical markers play a role in detection, such as stool tests, stool DNA tests, and a newer IBD marker. Calprotectin is a field protein found abundantly in the neutrophil, a type of white blood cell. It is released in significant amounts in the stool during intestinal inflammation. An algorithm has been developed that correlates the measured calprotectin levels in the stool to potential conditions, such as irritable bowel syndrome or IBD, which could be indicative of colon cancer.

New strategies are being developed to increase the diagnostic accuracy of colon cancer. In support of this study, TRI’s Biorepository is collecting remnant samples and TRI’s Device Trials team is performing testing to aid in collecting data in support of this new strategy.